MATRIFEN 50 MICROGRAMS/HOUR TRANSDERMAL PATCH

Transcript

PACKAGE LEAFLET: INFORMATION FOR THE USER

matrifen

®

Matrifen 12 micrograms/hour transdermal patch
Matrifen 25 micrograms/hour transdermal patch
Matrifen 50 micrograms/hour transdermal patch
Matrifen 75 micrograms/hour transdermal patch
Matrifen 100 micrograms/hour transdermal patch
Fentanyl
Important things you need to know about
Matrifen transdermal patches.
• These patches contain a strong pain killer
• Ensure that old patches are removed before
applying a new one
• Patches must not be cut
• Do not expose the patches to a heat source
(such as a hot water bottle)
• If you develop a fever tell your doctor
immediately
• Follow the dosage instructions carefully and
only change your patch every 3 days (72 hours)
• If your breathing becomes shallow and weak
take the patch off and seek medical help.
Read all of this leaﬂet carefully before you
start using this medicine because it contains
important information for you.
- Keep this leaﬂet. You may need to read it again.
- If you have further questions, please ask your
doctor, pharmacist or nurse.
- This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any
possible side effects not listed in this leaﬂet.
See section 4.
What is in this leaﬂet:
1. What Matrifen is and what it is used for
2. What you need to know before you use Matrifen
3. How to use Matrifen
4. Possible side effects
5. How to store Matrifen
6. Contents of the pack and further information
1. What Matrifen is and what it is used for
Matrifen transdermal patch contains the active
substance fentanyl. Fentanyl belongs to a group
of strong painkillers called opioids and acts
through blocking the pain signals to the brain.
Fentanyl is gradually released from the patch,
passes through the skin and into the body.
Matrifen is used for:
Adults:
Long term pain that can only be adequately
controlled by strong analgesics.
Children:
Long term management of severe chronic pain
in children receiving opioid therapy from 2 years
of age.
One transdermal patch relieves pain for
72 hours (3 days).
2. What you need to know before you use
Matrifen
Matrifen patches can be used in children aged
2 to 16 years who have previously used opioid
painkillers. If the patches have been prescribed
for your child, the ‘you’ stated everywhere
below should be read as ‘your child’.
Do not use Matrifen:
• If you are allergic to fentanyl or any of the
other ingredients of this medicine (listed in
section 6).
• If you suffer from short-term pain (e.g. after a
surgical procedure).
• If you have severe difﬁculties in breathing.
• If your central nervous system (e.g. your brain
or spinal cord) is severely impaired, for
instance by brain injury.
Warnings and precautions
WARNING
Matrifen is a medicinal product that could be
life-threatening to children.
This is also the case with used transdermal patches.
Bear in mind that the design of this medicinal
product could be tempting to a child which in
cases may lead to a fatal outcome. Matrifen can
have life-threatening side-effects in persons that
are not using prescribed opioid drugs on a
regular basis.
Patch sticking to another person
The patch should be used only on the skin of the
person for whom it was ordered by the doctor.
Cases have been reported where a patch was
accidentally stuck to a family member while in
close physical contact or sharing the same bed
as the patch wearer. A patch sticking to another
person (particularly a child) may result in an
overdose. In case the patch sticks to the skin of
another person, take the patch off immediately
and seek medical attention.
Before starting to use Matrifen you should
inform your doctor if you suffer from any of the
below disorders
• asthma, respiratory depression (reduced
ability to breathe) or any lung disease
• irregular heartbeat
• low blood pressure
• impaired liver function
• impaired kidney function
• if you have had a head injury or brain disease
(e.g. a tumor)
• if you suffer from a disease causing fatigue and
weakness of the muscles (myasthenia gravis)
• Matrifen may cause constipation, talk to your
doctor or pharmacist for advice on how to
prevent constipation.
Inform your doctor if you develop a fever during
the treatment, as the increased body temperature
may cause too much medicine to pass through
the skin.
For the same reason you should avoid exposing
the patch on the skin to direct heat such as
heating pads, electric blankets, hot-water bottles,
heated water beds, sauna, tanning lamps,
solarium, hot baths or hot water whirlpool spa
baths. You can shower while wearing a patch
and it is allowed to stay outside in the sun, but
you must protect the patch with some piece of
clothing during hot summer days.
The transdermal patches should not be divided
or cut.
Decreasing relief of pain (tolerance), physical or
psychological dependence may develop if you
use Matrifen for a longer period. However, this is
rarely seen during treatment of pain due to cancer.
Elderly patients should be monitored when
using Matrifen.
Children
Matrifen should not be given to children under
2 years of age or to children who have not
previously been treated with strong painkillers
such as morphine.
Other medicines and Matrifen
Tell your doctor or pharmacist if you are using,
have recently used or might use any other
medicines. Certain other medicines may affect
or be affected by Matrifen. Some of these
medicines are:
• Painkillers (e.g. opioids such as morphine and
codeine), as well as pentazocin, nalbuphine
and buprenorphine)
• Medicines to treat anxiety and tranquilisers,
sleeping medicines and general anaesthetics,
phenothiazines (medicine against psychosis)
• Sedating antihistamines (certain medicines
against allergy and travel sickness causing
drowsiness)
• Medicines used as muscle relaxants
• Some medicines used to treat epilepsy (such
as carbamazapine, phenobarbital or phenytoin)
• Rifampicin (for treatment of tuberculosis)
• Ritonavir and nelﬁnavir (against HIV)
• Itraconazole, ketoconazole, ﬂuconazole and
voriconazole (against fungal infections)

• MAO-inhibitors (e.g. moclobemide against
depression or selegiline against Parkinson’s
disease). You should not take Matrifen within
14 days of stopping these medicines
• Some medicines used to treat depression (such
as citalopram, duloxetine, escitalopram, ﬂuoxetine,
ﬂuvoxamine, paroxetine, sertraline, venlafaxine)
• Macrolide Antibiotics (e.g. erythromycin,
troleandomycin and clarithromycin)
• Nefazodone (against depression)
• Medicines to treat an irregular heartbeat, such
as amiodarone, diltiazem or verapamil.
Matrifen with alcohol
You should not drink alcohol whilst using Matrifen
patches, as this may increase the risk of serious
side effects and cause breathing difﬁculties, a fall
of blood pressure, extreme drowsiness and coma.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before
taking this medicine.
Safe use during pregnancy has not been established.
Fentanyl should not be used during childbirth since
fentanyl may cause difﬁculties in breathing in the
newborn child. Fentanyl is excreted into breast
milk and may cause sedation and respiratory
depression (reduced ability to breathe) in the
breast-fed child. Breast-feeding should therefore
be discontinued for at least 72 hours after removal
of the patch. Do not use Matrifen if you are
pregnant or breast-feeding unless your doctor
has weighed the risks of not using to be greater
than using Matrifen. Long-term treatment during
pregnancy may cause withdrawal symptoms in
the newborn child. If you get pregnant during
treatment with Matrifen, consult your doctor.
Driving and using machines
Fentanyl transdermal patch can make you drowsy;
if this happens do not drive, use tools or machinery.
The medicine can affect your ability to drive as it
may make you sleepy or dizzy.
• Do not drive while taking this medicine until
you know how it affects you.
• It is an offence to drive if this medicine affects
your ability to drive.
• However, you would not be committing an
offence if:
• The medicine has been prescribed to treat a
medical or dental problem and
• You have taken it according to the
instructions given by the prescriber or in the
information provided with the medicine and
• It was not affecting your ability to drive safely
Talk to your doctor or pharmacist if you are not
sure whether it is safe for you to drive while
taking this medicine.
3. How to use Matrifen
Always use this medicine exactly as your doctor has
told you. Check with your doctor or pharmacist if
you are not sure.
The dose is determined by your doctor, who will
adjust it for you individually. Always follow your
doctor’s instructions.
The recommended dose is one patch every three
days. According to your reaction the strength of
the patch or the number of patches may need to
be adjusted. The effect is reached within 24 hours
after the ﬁrst patch has been applied. Do not
discontinue treatment without consulting your
doctor.
Using and changing the patches
• There is enough medicine in each patch to
last 3 days (72 hours).You should change your
patch every third day, unless your doctor has
told you differently. Always remove the old
patch before applying a new one. Always
change your patch at the same time of day
every 3 days (72 hours).If you are using more
than one patch, change all your patches at
the same time.
• Make a note of the day, date and time you
apply a patch, to remind you when you need
to change your patch. On the outer package
you can write the date and time you applied
the patch to help you remember. The following
table shows you which day of the week to
change your patch:
Apply your patch on
Monday
Tuesday
Wednesday
Thursday
Friday
Saturday
Sunday

Change your patch
at the same time on
Thursday
Friday
Saturday
Sunday
Monday
Tuesday
Wednesday

Where to apply the patch
Adults
• Apply the patch on a ﬂat part of your upper
body or arm
Children
• Always apply the patch to the upper back to
make it difﬁcult for your child to reach it or
take it off
• Every so often check that the patch remains
stuck to the skin
• It is important that your child does not remove
the patch and put it in their mouth as this
could be life-threatening or even fatal
• It may take some time before the patch
becomes fully effective. Therefore, your child
might need additional painkillers until the
patches become effective. Your doctor will
advise you on this if it is needed
• Children should be monitored very closely for
48 hours after:
o The ﬁrst patch has been put on
o A higher dose patch has been put on
For you or your child, do not apply the patch on:
• The same place twice in a row.
• Sensitive areas that you move a lot, skin with
cuts, spots or other skin blemishes.
• Skin that is very hairy. If there is hair, do not
shave it (shaving irritates the skin). Instead,
clip the hair as close to the skin as possible.
You should allow several days to pass before
you put a new patch on the same area of skin.
Putting a patch on
Step 1: Preparing the skin.
• Make sure your skin is completely dry, clean
and cool before you put the patch on.
• If you need to clean the skin, just use cold water.
• Do not use soap or any other cleansers, creams,
moisturisers, oils or talc before applying the
patch.
• Do not stick a patch on straight after a hot
bath or shower.
Step 2: Open the pouch
• Each patch is sealed in its own pouch.
• Tear or cut open the pouch at the notch,
shown by the arrow.
• Gently tear or cut off the edge of the pouch
completely (if you use scissors, cut close to the
sealed edge of the pouch to avoid damaging
the patch).
• Grasp both sides of the opened pouch and
pull apart.

• Take the patch out and use straight away.
• Keep the empty pouch to dispose of the used
patch later.
• Use each patch once only.
• Do not take the patch out of its pouch until
you are ready to use it.
• Inspect the patch for any damage.
• Do not use the patch if it has been divided,
cut or looks damaged.
• Never divide or cut the patch.

Step 3: Peel and press
• Make sure that the patch will be covered by
loose clothing and not stuck under a tight or
elasticated band.
• Carefully peel one half of the shiny plastic
backing away from the centre of the patch.
• Try not to touch the sticky side of the patch.
Press this sticky part of the patch onto the skin.
• Remove the other part of the backing and
press the whole patch onto the skin with the
palm of your hand.
• Hold for at least 30 seconds. Make sure it
sticks well, especially the edges.
Step 4: Disposing of the patch
• As soon as you take a patch off, fold it ﬁrmly
in half so that the sticky side sticks to itself.
• Put it back in its original pouch and discard
according to local requirements or hand in to
your pharmacist
• Even used patches contain some medicine
which may harm children and may be fatal, so
keep your used patches out of the sight and
reach of children.
Step 5: Wash
• Wash your hands afterwards with clean water.
How quickly will the patches work?
• It may take up to a day before your ﬁrst patch
is working completely
• Your doctor may give you extra painkillers for
the ﬁrst day or so
• After this, the patch should help to relieve pain
continuously so that you can stop taking other
painkillers. However, your doctor may still
prescribe extra painkillers from time to time
If you use more Matrifen than you should:
If you or someone you know has stuck on too
many patches or the wrong strength patch, take
the patches off and contact your doctor or
hospital straight away. While waiting for the
doctor, keep the person awake by talking to or
shaking her/him now and then.
Signs of overdose include trouble breathing or
shallow breathing, tiredness, extreme sleepiness,
being unable to think clearly, walk or talk
normally and feeling faint, dizzy or confused.
If a patch sticks to another person (See also
section 2 above)
• Only use the patch on the skin of the person
who it was prescribed for.
• Make sure the patch does not get rubbed off
and stick to your partner or child, especially
while sharing a bed or in close contact.
• If a patch accidentally sticks to another
person, take it off straight away and seek
immediate medical attention.
How long will you use the patches for?
• Matrifen patches are for long-term pain. Your
doctor will be able to tell you how long you
can expect to use the patches.
If your pain gets worse
• If your pain gets worse while you are using
these patches, your doctor may try a higher
strength patch, or give you extra painkillers
(or both).
• If increasing the strength of the patch does
not help, your doctor may stop the patches.
If you forget to use or change your patch
• You should change your patch at the same
time every three days, if not otherwise
instructed by your doctor. If you forget to
change your patch, change it as soon as you
remember.
• If you are very late changing your patch, you
should contact your doctor because you
might need some extra painkillers, but do not
apply an extra patch.
If the patch falls off

• If the patch falls off before it needs changing,
stick a new one on straight away and make a
note of the day and time. Use a new area on:
- On your upper body or arm
- Your child’s upper back
Leave another 3 days (72 hours) before
changing the new patch as usual
• If your patch keeps falling off, talk to your
doctor, nurse or pharmacist.
If you stop using Matrifen
• Talk to your doctor before you stop using
these patches.
• If you have been using them for some time
your body may have got used to them.
Stopping suddenly may make you feel unwell.
• If you stop using the patches, don’t start again
without asking your doctor ﬁrst. You might
need a different patch strength when you
restart.
Everyday activities while using the patches
• The patches are waterproof.
• You can shower or bathe while wearing a
patch, but do not scrub the patch itself.
• You can also swim while wearing the patch, but:
o Don’t use hot whirlpool spa baths.
o Don’t put a tight or elasticated band over
the patch.
• Don’t expose the patch to direct heat such as
heating pads, hot-water bottles, electric
blankets, heated water beds, heat or tanning
lamps, intensive sun bathing, prolonged hot
baths or saunas. These may affect the way
the medicine is absorbed through the skin.
If you have any further questions on the use of
this medicine, ask your doctor, pharmacist or
nurse.
4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
If any of the following serious side effects occur,
you should remove the patch and immediately
contact your doctor or visit a hospital. You
may need urgent medical treatment:
• Feeling unusually drowsy, breathing more slowly
or weakly than expected.
• Very rarely these breathing difﬁculties can be
life-threatening or even fatal, especially in
people who have not used strong opioid
painkillers (like Matrifen or morphine) before.
If you, or your partner or carer, notice that you
or your child are breathing much more slowly
or weakly, keep moving and talking as much
as possible.
• Sudden swelling of the face or throat, severe
irritation, reddening or blistering of your skin.
These may be signs of a severe allergic reaction.
This only happens in a small number of people.
• Convulsions, ﬁts or seizures. This affects fewer
than 1 in 100 people.
• Reduced consciousness or loss of
consciousness. These affect fewer than 1 in
100 people.
Other side effects
Very common: may affect more than 1 in 10 people
• drowsiness
• dizziness
• headache
• feeling sick, being sick (vomiting)
• constipation.
Common: may affect up to 1 in 10 people
• hypersensitivity
• loss of appetite, difﬁculties in sleeping
• confusion, depression, anxiety, hallucinations
• shivering
• feelings of stinging in the skin (paraesthesia)
• feeling giddy
• irregular heartbeat, fast heart rate
• high blood pressure
• diarrhoea, dry mouth, stomach troubles
• sweating
• itching, rash, blushing
• muscle spasms
• difﬁculties in passing urine
• tiredness
• swelling of hands, ankles or feet
• weakness
• feeling of discomfort, feeling cold.

Uncommon: may affect up to 1 in 100 people
• loss of memory
• feeling agitated, disorientated, excited or
unusually carefree
• decreased feeling of sensitivity especially in
the skin
• slow heart rate
• bluish coloration of the skin
• low blood pressure
• obstruction of the bowel
• eczema and/or other skin disorders including
skin reactions where the patch is placed
• muscle twitching
• disorders of sexual function
• fever, ﬂu-like symptoms, body temperature
changes, drug withdrawal effects (being sick,
feeling sick, diarrhoea, anxiety or shivering).
Rare: may affect up to 1 in 1,000 people
• tiny pupils
• partial obstruction of the small or large bowel.
Additional side effects in children and adolescents:
Very common: may affect more than 1 in 10 people
• headache
• feeling or being sick
• constipation, diarrhoea
• itching
Common: may affect up to 1 in 10 people
• allergic reaction
• loss of appetite, stomach pain
• not being able to sleep, drowsiness, tiredness,
feeling weak
• feeling worried or depressed, hallucinations
(seeing, feeling or hearing things that are not
there)
• dizziness
• shaking, decreased feeling or sensitivity,
especially in the skin
• dry mouth
• rash, excessive sweating, redness of the skin
• muscle spasms
• difﬁculty passing urine
• swelling of hands, ankles or feet
• skin reactions where the patch is placed
Uncommon: may affect up to 1 in 100 people
• confusion
• sensation of pins and needles
• tiny pupils
• feeling giddy
• bluish colouration of the skin, eczema and/or
other skin disorders including dermatitis
where the patch is placed
• drug withdrawal effects (such as sickness,
feeling sick, diarrhoea, anxiety or shivering),
ﬂu-like symptoms
Other adverse reactions
Decreasing relief of pain (tolerance), physical
and psychological dependence can develop
during long-term use of fentanyl.
Opioid withdrawal symptoms (such as: feeling
sick, being sick, diarrhoea, anxiety and shivering)
are possible in some patients after conversion
from their previous opioid analgesics to Matrifen
transdermal patch.
Skin rashes, itching or sweating (affects less than
1 in 10 people). You may notice rashes, redness
or slight itching of the skin at the site of the patch.
This is usually mild and disappears after you have
removed the patch. If it does not, or if the patch
irritates your skin badly, tell your doctor.
Reporting of side effects
Reporting suspected adverse reactions after
authorisation of the medicinal product is
important. It allows continued monitoring of the
beneﬁt/risk balance of the medicinal product.
Healthcare professionals are asked to report any
suspected adverse reactions via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard.
5. How to store Matrifen
Keep unused and used patches out of the sight
and reach of children. High quantities of the
drug remain in the transdermal patches even
after use.
Do not use Matrifen after the expiry date stated
on the package. The expiry date refers to the last
day of that month.
This medicinal product does not require any
special storage conditions.
Handling the patch
Accidental exposure to used and unused patches
particularly in children may lead to a fatal outcome.
Used patches should be folded so that the
adhesive side of the patch adheres to itself and
then they should be safely discarded. Unused
patches should be returned to the hospital or
pharmacy.
Do not throw away any medicines via wastewater
or household waste. These measures will help
protect the environment.
6. Contents of the pack and other information
What Matrifen transdermal patch contains
The active substance is: Fentanyl.
The patches come in 5 different strengths
(see table below).
Name of patch:
Matrifen 12
micrograms/hour
transdermal patch
Matrifen 25
micrograms/hour
transdermal patch
Matrifen 50
micrograms/hour
transdermal patch
Matrifen 75
micrograms/hour
transdermal patch
Matrifen 100
micrograms/hour
transdermal patch

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.